The field of the invention pertains to medical appliances and, in particular, to devices that can be attached to the exterior skin of a person about or in an opening with the purpose of accepting and containing any solid or liquid material flowing from the opening. Such devices require a means of attachment that does not damage the skin but is reasonably secure.
Lognion, U.S. Pat. No. 4,496,356, discloses an anal excretion collecting rectal catheter that is insertable beneath the sphincter muscles about the opening. The Lognion device comprises a collecting tube open at one end with a resilient ring that fits within the rectal opening.
Wade, U.S. Pat. No. 2,564,773, discloses a therapeutic agent comprising a thimble and latex bag insertable into a bodily opening for the collection of fluids. The bag folds within the thimble before use and may be attached to the thimble with an adhesive. The thimble includes an opening for the admission of fluids and is directly insertable into the bodily opening.
Wayne, U.S. Pat. No. 2,448,938 and Swiss Pat. No. 113 453 each disclose a sanitary protective appliance of similar structure to receive bodily fluids and semi-solids from infections and incisions. The appliances comprise soft thin rubber tubes of accordion like shape with an opening of relatively large diameter. On the inside surface adjacent the opening is an adhesive ring to enable the device to be adhesively attached to the skin about the body opening from which there is a discharge.
Chen et al., U.S. Pat. No. 4,253,460 and Allen, Jr. et al., U.S. Pat. No. 4,650,817 both disclose adhesives suitable for attaching appliances such as ostomy devices to the skin about a body opening. Such adhesives must be secure, reasonably fluid tight but nevertheless easy to remove without damage to the skin.
U.S. Pat. No. 3,522,807 discloses an incontinence bag that has a pleated arrangement about the anus to expand and contract with the opening and closing of the anus. The overlapping leaves of the pleats do not provide for complete adhesive attachment to the skin thus permitting leakage and providing a difficult attachment.
U.S. Pat. No. 4,445,898 discloses a foam backed skin barrier attachment and incontinence bag. The skin barrier is disclosed as soft, pliable, stretchable and contractable foam backed plastic 0.080 to 0.400 inches thick. Plastic backed by foam has limited stretchability if less than 25% which limits the expandability of the anal hole in the skin barrier to an amount less than needed for many patients. In such cases, the anus can not open sufficiently thereby causing severe pain or the adhesive fails and the bag detaches and leaks.
Devices insertable within body openings have been found to cause permanent damage to the sphincter muscles after prolonged use. With a view toward overcoming and avoiding damage to the sphincter muscles of the anal opening but nevertheless providing a secure receptacle for body waste that does not damage the skin surrounding the anus, is sufficiently elastic (an elastic limit of about 200% or more) to accomodate the full opening of the anus and is easy to install the following described incontinence device has been developed.